This resource identifies an instance or a type of a A manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device. Medical devices include durable (reusable) medical equipment, implantable devices, as well as disposable equipment

Allows institutions to track their devices.

Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

Certain attributes, like serial number and UDI Carrier (the HRF or AIDC barcode string) are not device instance identifiers as they are not consistently able to uniquely identify the instance of a device, thus are not appropriate to be used to value Device.identifier. The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. For UDI , this element corresponds to the variable portion of the UDI that identifies The identifier is typically valued if the serial number of a specific device. See UDI mappings for serialNumber or lotNumber is not valued and represents a complete mapping different type of UDI parts identifier. However, it is permissible to Device. still include those identifiers in DeviceDefinition.identifier with the appropriate identifier.type.

The reference to the definition for the device.

Unique Device Identifier (UDI) placed on a device label or package. Note that the Device may include multiple UDIs if it is sold in multiple jurisdictions.

UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.

The device identifier (DI) (UDI-DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device. The UDI-DI portion is placed on a device label or package. Note that the DeviceDefinition may include multiple UDI-DIs if it is sold in multiple jurisdictions.

Name of device as Establishes the namespace for the issuing agency's system (e.g, GS1's GTIN, ICCBBA's ISBT-128) used in labeling or catalog. to create the device identifier.

Use the Device.type Organization that is charged with issuing UDIs for a generic type or kind of device name. Note devices. For example, the GUDID US FDA issuers include:

1. GS1: http://hl7.org/fhir/NamingSystem/gs1-di,
2. HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-diI,
3. ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di,
4. ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di # Informationsstelle für Arzneispezialitäten (IFA GmbH) (EU only): http://hl7.org/fhir/NamingSystem/ifa-gmbh-di.

The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace. namespace with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi. http://hl7.org/fhir/NamingSystem/us-fda-udi or in the European Union by the European Commission http://hl7.org/fhir/NamingSystem/eu-ec-udi.

Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.

The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - E.g e.g., a barcode , 2D Matrix, or RFID. Because of limitations on character sets in XML Some AIDC representations contain non-printable characters and the need to round-trip JSON data through XML, cannot be represented in a string format. For this reason, AIDC Formats format SHALL be base64 base64Binary encoded.

The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

Organization that is charged with issuing UDIs for devices. For example, The full UDI carrier as the US FDA issuers include : 1) GS1: http://hl7.org/fhir/NamingSystem/gs1-di, 2) HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, 3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, 4) ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di. human readable form (HRF) representation as printed on the packaging of the device.

If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

A coded entry to indicate how the data was entered.

Supports a way to distinguish hand entered from machine read data.

Status The Device record status. This is not the status of the Device device like availability.

Code or identifier to identify a kind The availability of the device.

Lot number assigned by A production identifier of the manufacturer. donation, collection, or pooling event from which biological material in this device was derived.

Necessary to support mandatory requirements for traceability from donor/source to recipient and vice versa, while also satisfying donor anonymity requirements. The element is defined consistently across BiologicallyDerivedProduct, NutritionProduct, and Device. The identifier references an event that links to a single biological entity such as a blood donor, or to multiple biological entities (e.g. when the product is an embryo or a pooled platelet product). A single biologicalSourceEvent identifier may appear on multiple products of many types derived from a single donation event or source extraction. As an example, a single donation event may provide 2 kidneys and a liver for organ transplantation, 2 corneas for eye surgery, heart valves and arterial tissue for cardiovascular surgery, multiple skin grafts, tendons, multiple shaped bone grafts and a large number of bone putty/paste products; and each of them may be assigned to the same biological source event identifier.

A name of the manufacturer. manufacturer or entity legally responsible for the device.

The date and time when the device was manufactured.

The date and time beyond which this device is no longer valid or should not be used (if applicable).

Lot number assigned by the manufacturer.

The "model" is an serial number assigned by the organization when the device was manufactured.

Alphanumeric Maximum 20. While a serial number is a type of identifier, in the context of devices for which a UDI is required, thus a serial number may be part of the production identifier, it is more informative to identify have the product by serial number as a dedicated attribute together with the other UDI production identifier. When the device is not subject to including the UDI (e.g., its presence and exchange is not mandated by local regulatory requirements or specific use case at hand), thus the concept of production identifiers is not relevant as a set, it remains helpful for consistency to still use Device.serialNumber rather than using Device.identifier with an appropriate type. This Systems that do not realize an identifier is a serial number may place it in Device.identifier or if the identifier.system is shared by known for the all devices sold serial number, it may also be populated in the Device.identifier as a globally unique id_.

This represents the same type. manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition.

The actual name that identifies the device.

Indicates the kind of name. RegisteredName | UserFriendlyName | PatientReportedName.

The version of the device, if implementation or jurisdiction must clarify which name is to be used as the registered-name. As a result a device has definition may have multiple releases under names that are the same model, or if same, but then used for different purposes per the device is software name type and jurisdictional guidance.

Indicates the default or carries firmware. preferred name to be displayed.

The manufacturer's model number for the device.

The part number or catalog number of the device.

Patient information, If Alphanumeric Maximum 20.

Devices may be associated with one or more categories.

The kind or type of device. A device instance may have more than one type - in which case those are the types that apply to a person. the specific instance of the device.

Multiple device types are use when a device is categorized in more than one context – for example, hybrid devices in which the device is both of type gateway and sensor. Device.type relates DeviceDefinition.classification.type using the same binding enabling referencing.

The actual design of the device or software version running on the device.

The combination of type and component SHOULD be unique across all repetitions of version.

The type of the device version, e.g. manufacturer, approved, internal.

If The hardware or software module of the device is implanted in a patient, then need to associate which the version applies.

Note that the module of the device would not need to be tracked as a separate device, e.g., using different UDI, thus would typically involve one or more software modules. For example, a device may involve two software modules each on a different version.

The date the version was installed on the device.

An organization that is responsible The version text.

Identifies the standards, specifications, or formal guidances for the provision and ongoing maintenance of capabilities supported by the device. The device may be certified as conformant to these specifications e.g., communication, performance, process, measurement, or specialization standards.

Describes the type of the standard, specification, or formal guidance.

Code that identifies the specific standard, specification, protocol, formal guidance, regulation, legislation, or certification scheme to which the device adheres.

Contact details for an organization Identifies the specific form or variant of the standard, specification, or formal guidance. This may be a particular human that 'version number', release, document edition, publication year, or other label.

Static or essentially fixed characteristics or features of the device (e.g., time or timing attributes, resolution, accuracy, intended use or instructions for use, and physical attributes) that are not otherwise captured in more specific attributes.

Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific [DeviceMetric] and recorded using [Observation]. Static characteristics of a device could also be documented in an associated [DeviceDefinition] instance. The Device instance's properties, and their values, could be, but need not be, the same as those described in an associated DeviceDefinition.

Code that specifies the property, such as resolution, color, size, being represented.

The value of the property specified by the associated property.type code.

The text element in CodeableConcept.text is used for troubleshooting etc. properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g. a custom implant size, or a security classification which depends on configuration). Otherwise the string choice type is used for descriptive properties, or instructions.

Material added to a container device (typically used in specimen collection or initial processing). The place where material may be added by the device manufacturer or by a different party subsequent to manufacturing.

A Procedure can be found. used to document details of the addition of a substance to the device.

The type of the substance added to the container. This is represented as a concept from a code system or described in a Substance resource.

Device.location can The quantity of the additive substance in the container; may be used to track device location. volume, dimensions, or other appropriate measurements, depending on the container and additive substance type.

A network address on which Contact details for an organization or a particular human that is responsible for the device may be contacted directly. device.

used for troubleshooting etc.

If The place where the device is running a FHIR server, the network address should can be found.

Device.location can be retrieved. used to track device location.

Descriptive information, usage information or implantation information that is not captured in an existing element.

Provides additional safety characteristics about a medical device. For example devices containing latex.

The higher level or encompassing device that this device is a logical part of.

For example a vital signs monitor (parent) where three separate modules can be plugged into such as interchangeable blood pressure, oximeter, temperature modules. These modules are represented as devices with the .parent valued to the vital signs monitor when plugged in.